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The Effects of DPPIs on Cognitive Function of Diabetic Patients

NCT ID: NCT06164535

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-30

Study Completion Date

2024-07-15

Brief Summary

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This is a single-center, randomized controlled clinical trial with a parallel-group design conducted at Minia University hospital.

Detailed Description

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All patients admitted to Diabetes clinics of Minia University Hospital, will be screened for the eligibility criteria.

diabetic patients (aged above 50 years) with uncontrolled diabetes on oral hypoglycemic drugs. 105 patients will be enrolled and randomized into three groups.

Group I=35 T2DM patients given DPP4Is Group II=35 T2DM patients given DPP4Is and metformin. Group III=35 patients will be given placebo (only adjust their drugs to control blood glucose level)

Conditions

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Cognitive Impairment

Keywords

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Cognitive DPP-4 inhibitors Diabetes Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
all patient information will be anonymized giving only corresponding numbers, which will be revealed by the PI after assessment.

Study Groups

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Control Group

35 patients will be given placebo (only adjust their drugs to control blood glucose level)

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type DRUG

35 T2DM patients will be given placebo (only adjust their drugs to control blood glucose level)

DPPI Group

35 T2DM patients will be given DPP4Is once or twice daily

Group Type EXPERIMENTAL

DPP-4 inhibitor group

Intervention Type DRUG

35 T2DM patients will be given DPP-4 I once or twice daily

DPPI + metformin group

35 T2DM patients will be given DPP4Is + metformin once or twice daily

Group Type EXPERIMENTAL

DPP-4 inhibitor + metformin group

Intervention Type DRUG

35 T2DM patients will be given DPP-4 I + metformin once or twice daily

Interventions

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Control group

35 T2DM patients will be given placebo (only adjust their drugs to control blood glucose level)

Intervention Type DRUG

DPP-4 inhibitor group

35 T2DM patients will be given DPP-4 I once or twice daily

Intervention Type DRUG

DPP-4 inhibitor + metformin group

35 T2DM patients will be given DPP-4 I + metformin once or twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Type-2 diabetic adult subjects (above 50 years old) who had uncontrolled (A1c=8-9 %) blood glucose levels with an oral hypoglycemic drug at the screening visit were eligible to participate.

Exclusion Criteria

Those with type1 diabetes or ketoacidosis, end organ failure as chronic renal failure (estimated serum creatinine level ≥ 1.5mg/dl in male and ≥ 1.4mg/dl in female), liver cell failure (elevated alanine transaminase (ALT) and aspartate transaminase (AST) ≥ 2 folds), and heart failure, previous history of pancreatitis, and pregnant or lactating females were excluded from the study.
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Pharmacy Department, Faculty of Pharmacy, 6 October University

UNKNOWN

Sponsor Role collaborator

Faculty of Medicine, Minia University

UNKNOWN

Sponsor Role collaborator

Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Abdelfattah Elsayed

Lecturer of clinical pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Minia University hospital

Minya, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Asmaa Elsayed

Role: CONTACT

Phone: +201095727201

Email: [email protected]

Engy Wahsh

Role: CONTACT

Email: [email protected]

Facility Contacts

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Asmaa Elsayed

Role: primary

Other Identifiers

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BeniSuefU2023

Identifier Type: -

Identifier Source: org_study_id